- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04855227
A Prospective Evaluation of Pain After Non-complex Ventral Hernia Repair (ASPIRE)
ASPIRE: A proSpective Evaluation of PaIn After Non-complex ventRal hErnia Repair
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Smruthi Srinivasa Murthy, MS
- Phone Number: 682-552-6131
- Email: smruthi.srinivasamurthy@intusurg.com
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85027
- Recruiting
- Desert Surgical Specialists
-
Contact:
- Angela Durrani
- Email: manager@desertsurgeon.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Subject is between 18 and 80 years of age.
- Subject is a candidate for an elective primary (non-recurrent) ventral hernia repair.
- Ventral hernia repair that will require mesh placement
Exclusion Criteria:
- Subject is contraindicated for general anesthesia or surgery.
- Subject with a ventral hernia that will require retromuscular mesh placement or employ a technique, including (but not limited to) external oblique release, Rives- Stoppa, eTEP Rives-Stoppa, transversus abdominis release, other component separation techniques (i.e. anterior component separation) or eTEP transversus abdominis release.
- Subject has a recurrent hernia.
- Subject who will have an emergent hernia repair.
- Subject with a history of chronic pain and/or taking daily pain medications for >6 weeks.
- Subject with a history of substance abuse (excluding marijuana) and/or current (within 30 days) narcotic use.
- Current marijuana use that the subject is unwilling to discontinue within the 14 days prior to surgery.
- Subject with a history of MRSA infection.
- Subject with HbA1c level > 8.5%.
- Use of Exparel during the surgical procedure.
- Subject who will undergo a concomitant hernia repair or any other concomitant procedure.
- Current nicotine use (including vaping) within the past 30 days.
- Subject has a known bleeding or clotting disorder.
- Pregnant or suspected pregnancy.
- Subject is mentally handicapped or has a psychological disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent.
- Subject belonging to other vulnerable population, e.g, prisoner or ward of the state.
- Subject is currently participating in another interventional or investigational research study.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Laparoscopic ventral hernia repair
These subjects will undergo a laparoscopic primary umbilical or incisional hernia repair.
|
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Robotic-assisted ventral hernia repair
These subjects will undergo a robotic-assisted primary umbilical or incisional hernia repair.
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Laparoscopic ventral hernia repair With the subject under general anesthesia, several small incisions are made in the abdomen. Ports are placed, the abdomen is insufflated, and laparoscopic instruments as well as a laparoscope are inserted to complete the repair. The retrorectus space is developed for mesh placement to repair the defect. The repair technique will be per the surgeon's standard of care. Robotic-assisted ventral hernia repair With the patient under general anesthesia, several small incisions are made in the abdomen. Ports are placed, the abdomen is insufflated, and the da Vinci Robotic Surgical System (Intuitive) is docked to the subject and used to complete the procedure. The retrorectus space is developed for mesh placement to repair the defect. The repair technique will be per the surgeon's standard of care.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in pain score assessed by the PROMIS 3a from baseline to 14 days
Time Frame: 14 days
|
Change in patient reported pain scores assessed by the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey, with a scale from 1-5; 1 meaning no pain and 5 meaning severe pain.
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14 days
|
Change in narcotic usage from 1 day post-procedure to 14 days post-procedure
Time Frame: 14 days
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Narcotic usage after the ventral hernia repair as determined through use of a patient reported pain medication log.
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14 days
|
Change in pain score assessed by the NRS from baseline to 14 days
Time Frame: 14 days
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Change in patient reported pain scores assessed by the Numeric Rating Scale (NRS) from 1-10, where 0 indicates no pain and 10 indicates the worst pain imaginable.
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14 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in narcotic usage from 1 day post-procedure to 30 days post-procedure
Time Frame: 30 days
|
Narcotic usage after the ventral hernia repair as determined through use of a patient reported pain medication log.
|
30 days
|
Change in OTC pain medication usage from 1 day post-procedure to 30 days post-procedure
Time Frame: 30 days
|
Over the counter (OTC) pain medication usage after the ventral hernia repair as determined through use of a patient reported pain medication log.
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30 days
|
Need for refill prescription pain medication usage from 1 day post-procedure to 30 days post-procedure
Time Frame: 30 days
|
Need for refill narcotic prescription pain medication usage
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30 days
|
Change in Quality of Life assessment: EQ-5D-3L (EQ) from baseline to 14 days
Time Frame: 14 days
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Quality of life assessment using the EQ-5D-3L (EQ) assessment tool, with scores on individual questions ranging from no problems to extreme problems, with a scale of health ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine)
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14 days
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Change in Quality of Life assessment: EuraHS-QOL from baseline to 30 days
Time Frame: 30 days
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Quality of life using the EuraHS-QOL assessment tool, with scores on questions relating to pain, restrictions of movement, and cosmetic discomfort; with a scale ranging from 0 (no pain/no restriction/very beautiful) to 10 (worst pain/completely restricted/extremely ugly).
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30 days
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Length of hospital stay (LOS)
Time Frame: Procedure start time to discharge from the hospital (check out time), up to an approximate of one week
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How long the patient was admitted to the hospital
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Procedure start time to discharge from the hospital (check out time), up to an approximate of one week
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Incidence of intraoperative adverse events related to the ventral hernia repair
Time Frame: Intraoperative
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Intraoperative adverse events related to the ventral hernia repair
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Intraoperative
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Incidence of postoperative adverse events related to the ventral hernia repair through 30 days post-procedure
Time Frame: 30 days
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Post-operative adverse events related to the ventral hernia repair
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30 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASPIRE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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